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Completed

NCT Number: NCT04667884

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional constipation.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults: 18 to 70 years old (not less than 50% of the final population over 45 years old, and not less than 30% of men);
  • Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); * Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months

Exclusion criteria

  • Pregnant and lactating women;
  • Unable to take the test sample and complete the inspection items as required due to inability to take food by mouth, weakness, allergies or other reasons (including the inability to complete all items due to recent travel plans);
  • Unclear main complaint and obvious abnormal mental state;
  • The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);
  • Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;
  • Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week
  • Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;
  • Have been diagnosed with the following diseases: severe systemic diseases such as stroke, heart disease, liver cirrhosis, renal failure, hematopoietic system, or qualitative intestinal diseases caused by colonoscopy or imaging display;
  • In the past 3 months, there are often abdominal pain, abdominal pain accompanied by changes in bowel characteristics or frequency, blood in the stool, diarrhea or involuntary weight loss;
  • Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.

Treatment and study plan

Prebiotics or Probiotics

Dietary Supplement

All the supplements were provided in solid drinks,and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.

Primary outcomes

  1. Number of bowel movements per week

    Time frame: week 0 to 4

    bowel movements will be recorded per week

Secondary outcomes

  1. Classification of bowel status

    Time frame: day 0, 14, 28

    Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation

  2. Bristol classification of stool characteristics

    Time frame: day 0, 14, 28

    Bristol classification

  3. glucose

    Time frame: day 0, 14, 28

    Fasting plasma

  4. HDL-C

    Time frame: day 0, 14, 28

    Fasting plasma

  5. LDL-C

    Time frame: day 0, 14, 28

    Fasting plasma

  6. TG

    Time frame: day 0, 14, 28

    Fasting plasma

  7. Tch

    Time frame: day 0, 14, 28

    Fasting plasma

  8. diversity and abundance of intestinal flora

    Time frame: day 0, 14, 28

    16s rRNA

Sponsors and collaborators

Lead sponsor

Xi'an Jiaotong University

Other

Registry information

Official study title

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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